Device Dossier

Bi-Cruciate Stabilised (BCS) Knee System Patella Resurfacing - Polyethylene patella prosthesis

Device Dossier for Bi-Cruciate Stabilised (BCS) Knee System Patella Resurfacing - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class…

Intended purpose

The JOURNEY BCS Knee System is indicated for: • Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. • Failed osteotomies, unicompartmental replacement, or total knee replacement. • Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent, and the collateral ligaments remain intact. • Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. • The device is indicated for use only in surgeries where the patella is resurfaced.

Functional description

An implantable artificial kneecap (patellar component) made of polyethylene (PE) and implanted during primary knee joint replacement. It is a sterile device which is designed to articulate with a femoral component. It is affixed to the natural patella with bone cement after reaming or resecting and drilling three holes into the natural patellar.

TGA Public Summary